HEALTHCARE LAW
ORTHPARTNERS advises companies and organizations in the healthcare industry on all key regulatory issues, from the initial product concept through approval to implementation in hospitals, medical practices, and healthcare settings.
We understand the unique market, compliance, and liability risks inherent in a highly regulated environment and translate complex requirements into pragmatic, economically viable solutions. Our focus is on the business perspective within the healthcare sector. Â
We support manufacturers, operators, investors, and service providers throughout the entire lifecycle of their business models. In doing so, we take an interdisciplinary approach to the healthcare industry: corporate law, regulation, compliance, data protection, and liability issues are all closely intertwined in this sector.
OUR SERVICES
An excerpt.
Pharmaceutical Law and Regulatory Approval Processes: Advice on national and European regulations, development, collaboration, and licensing agreements, market access, regulatory approval, pharmacovigilance, and interactions with regulatory authorities.
Medical device law and digital health applications: Support with classification, conformity assessment, CE marking, market surveillance, and the regulatory classification of digital solutions and AI-based medtech products.
Professional law for healthcare professions and medical law: structuring cooperation and partnership models that comply with professional regulations, medical center structures, practice establishment and employment, as well as compensation and compliance issues.
Hospital Law, Statutory Health Insurance Law, and Hospital Operating Structures: Advising hospital operators, hospital networks, and investors on strategic direction, cooperation and operational models, as well as on restructuring and transactions, and on issues related to service provision, remuneration, reimbursement, and medical malpractice law.
Pharmacy Law and Pharmaceutical Care: Licensing and operation, purchase and sale of pharmacies, general partnerships, mail-order and online models, wholesale, and advertising and discount structures within regulatory limits.
AI in Healthcare: Legal support for the use of artificial intelligence in the medical field, particularly with regard to AI-enabled medical devices and clinical decision-making systems, in conjunction with EU regulations (including the AI Act) as well as medical device, data protection, and hospital law.
